Crohn Disease Clinical Trial
— RUN-CDOfficial title:
Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease in Conjunction With Long-term Outcome
NCT number | NCT03108326 |
Other study ID # | bio101 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 15, 2017 |
Est. completion date | March 31, 2023 |
"RUN-CD" is an investigator initiated "Non interventional Trial" on biologics in Crohn´s Disease (CD) patients in Germany with a prospective documentation of effectiveness in induction and maintenance therapy of biologics, especially of Ustekinumab, with a special interest on predictors of long-term responses and favorable disease outcome and documentation of severe side effects caused by the therapy with biologics.
Status | Recruiting |
Enrollment | 900 |
Est. completion date | March 31, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: CD-patients aged 18-80 years at enrollment written informed consent is given Exclusion Criteria: planned surgical intervention malignant disease in history lack of adequate documentation possibilities |
Country | Name | City | State |
---|---|---|---|
Germany | Gastroenterologische Gemeinschaftspraxis Minden | Minden | Niedersachsen |
Lead Sponsor | Collaborator |
---|---|
Ced Service GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of induction therapy in CD-patients treated with Ustekinumab. | clinical remission HBI = 4 at week 16 | Week 0 till 16 | |
Secondary | Effectiveness of induction therapy at week 8 in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab. | clinical remission HBI = 4 at week 8 | Week 0 till 8 | |
Secondary | Effectiveness of maintenance therapy up to 3 years in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab. | clinical remission HBI = 4 at year 3 | Week 0 till year 3 | |
Secondary | Effectiveness of Ustekinumab in different subpopulations | e.g. based on prior biologics therapy or clinical parameters/phenotype at baseline in comparison with the other biologics-group. or clinical parameters/phenotype at baseline in comparison with the other biologics-group. |
Week 0 till year 3 | |
Secondary | Measurement of disease activity with HBI | HBI= Harvey-Bradshaw-Index (e.g. steroids), co-morbidities and adverse events. | Week 0 till year 3 | |
Secondary | Measurement of Quality of Life with EQ-5D questionnaire | EQ-5Dâ„¢ is a standardised instrument for use as a measure of health outcome | Week 0 till year 3 | |
Secondary | Measurement of disease activity with CDAI | CDAI = Crohn's Disease Activity Index | Week 0 till week 16 |
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